Quality Engineering Lead

OverviewThe Quality Engineering Manager serves as the technical leader for Quality Engineering, driving quality systems, supplier quality, CAPA effectiveness, regulatory compliance, and continuous improvement initiatives across the organization. This role partners with Operations, Engineering, Manufacturing, Supply Chain, and Customer Experience to ensure products consistently meet regulatory, customer, and internal quality requirements while improving supplier, manufacturing, and customer-facing quality performance.Key ResponsibilitiesQuality Systems & ComplianceOwn and continuously improve the Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, ISO 9001, and applicable regulatory requirements.Maintain Design Controls, DHFs, DMRs, document control, training compliance, traceability, record retention, and regulatory reporting requirements.Develop quality metrics, dashboards, and reporting to evaluate organizational performance.Support Management Reviews and present quality performance trends and recommendations to leadership.CAPA, Investigations & Complaint ManagementLead the CAPA program, including investigations, root cause analysis, corrective and preventive actions, and effectiveness verification.Facilitate RCCA, 8D, DMAIC, and other structured problem-solving methodologies.Analyze complaints, nonconformances, supplier issues, and quality trends to identify systemic improvement opportunities while maintaining regulatory compliance.Supplier Quality ManagementOwn and improve the Supplier Quality Management System (SQMS).Develop supplier qualification, onboarding, monitoring, requalification, and performance management processes.Conduct supplier audits, capability assessments, process reviews, and first article inspections.Lead supplier corrective actions and supplier development initiatives in partnership with Procurement and Operations.Regulatory Compliance & Audit ReadinessServe as a primary quality representative during FDA inspections, ISO audits, customer audits, and certification assessments.Plan and support internal audits, ensure timely closure of findings, and maintain organizational compliance with applicable regulations and standards.Support risk management activities and inspection readiness efforts.Product Quality & Customer ExperienceInvestigate customer complaints and product quality issues to identify root causes related to design, manufacturing, suppliers, or product usage.Analyze field performance, production, inspection, and customer feedback data.Partner with cross-functional teams to implement containment actions and long-term improvements.Drive quality improvement initiatives focused on defect reduction, process capability, customer satisfaction, and operational performance.Utilize Lean Manufacturing, Six Sigma, process validation, risk reduction, and structured problem-solving methodologies.Facilitate Kaizen events, value stream improvements, and cross-functional improvement projects.Cross-Functional LeadershipServe as the Quality Engineering subject matter expert for quality systems, supplier quality, compliance, and continuous improvement.Partner with Operations, Engineering, Manufacturing, Supply Chain, and Executive Leadership to align quality objectives with business priorities.Establish and monitor KPIs, leveraging data-driven insights to drive accountability and measurable business impact.QualificationsBachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related technical discipline.7+ years of Quality Engineering experience in a regulated manufacturing environment.Experience leading quality initiatives, supplier quality programs, QMS development, and continuous improvement efforts within FDA-regulated and/or ISO 13485 environments.Strong expertise in CAPA, complaint handling, nonconformance management, risk management, audits, Design Controls, V&V, process validation, and product lifecycle quality management.Experience conducting supplier audits, capability assessments, supplier development activities, and supporting FDA, ISO, and customer audits.Proficiency with RCCA, 8D, DMAIC, Fishbone, 5-Why, and other root cause analysis methodologies.Strong communication, stakeholder management, and cross-functional leadership skills.CQE, CMQ/OE, or equivalent certification preferred.Experience in medical device, dental, life sciences, aerospace, or other highly regulated manufacturing environments preferred.Why SKDLA?Inclusive, collaborative culture.Significant growth and career advancement opportunities.Competitive compensation and comprehensive benefits.401(k) with employer match for eligible employees.Salary Range$130,000–$150,000Spectrum Killian Dental Lab Alliance is an Equal Opportunity Employer committed to fostering an inclusive workplace for all employees.Please noteAll candidates must apply through the official application process. To maintain an equitable and efficient recruiting experience, we ask that applicants refrain from contacting hiring managers, executives, department leaders, or other Spectrum Killian employees directly regarding this position. Candidates selected to move forward in the process will be contacted by a member of our Talent Acquisition team.#J-18808-Ljbffr